Insulet said its long-troubled Billerica, MA manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.
It was attention-grabbing when California sued a handful of drugmakers, accusing them of lying about the safety of their high-powered painkillers and blaming them for an epidemic of prescription drug overdoses and a resurgence in heroin use. But from a legal standpoint, a California judge has ruled, there is not much there to stand on.
Pfizer has no problem keeping sales for Viagra flying high in China, where brand awareness campaigns and changing attitudes toward sex have given it a sizable hold on the ED market. But the company is facing some headwind in the country, as Chinese marketing authorities slapped Pfizer with a fine for paying local drugstores to promote its blockbuster ED med.
The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier.
Amgen scored the big win for its PCSK9 drug Repatha (evolocumab). The FDA announced Thursday afternoon that it has given Amgen a green light on marketing the PCSK9 cholesterol drug, opening the door to what will likely prove a blockbuster market.
The FDA slapped Cepheid with a warning letter for violations at its European R&D and manufacturing site in Sweden, chastising the company for the way it went about producing its Xpert Norovirus diagnostic.
After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.
It has been more than 6 years since Caraco Pharmaceutical Laboratories was forced to suddenly shut two Detroit-area manufacturing plants after the FDA sent in marshals to seize drugs, claiming the plants had contamination issues. One of the plants was even closed last year by Caraco owner Sun Pharmaceutical. But legal problems continue to reverberate for Sun for having laid off hundreds of workers without notice.
The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.
A lab dedicated to biocompatibility and medical device testing to be based in India's western Gujarat state, a manufacturing hub, would mark a first and has received backing from the federal government with hopes of getting state officials to offer funds as well.